510(k) · Cleared
ClearedFlexible Endoscopic Scissors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Telemed Systems, Inc. · OCZ Endoscopic Grasping/Cutting Instrument, Non-Powered
Cleared on Apr 2, 2001 after a 49-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Apr 2, 2001
- Review
- 49 days
- Class
- Class II
- Product code
- OCZ
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK010412 Flexible Endoscopic ScissorsTelemed Systems, Inc. · 2001
- Descendant · cites it directly · 4 of its ownK090583 Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009
- Descendant · 2 generations on · 3 of its ownK141058 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014
- Descendant · 3 generations on · 2 of its ownK150939 Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2015
- Descendant · 4 generations on · 0 of its ownK242923 SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip…Envision Endoscopy · 2024
- Descendant · 2 generations on · 0 of its ownK180134 Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC · 2018
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K090583Endoscopic Monopolar Scissors, Models Ems-235, Ems-165Apollo Endosurgery, Inc. · 2009 · cites it directly4descendants
- K141058Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2014 · 2 generations on3descendants
- K150939Ensizor Endoscopic ScissorsSlater Endoscopy, LLC · 2015 · 3 generations on2descendants
- K242923SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture Cutter…Envision Endoscopy · 2024 · 4 generations on0descendants
- K180134Ensizor Monopolar Endoscopic ScissorsSlater Endoscopy, LLC · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010412 | Flexible Endoscopic Scissors | Telemed Systems, Inc. | 2001 | — |
| +1 | K090583 | Endoscopic Monopolar Scissors, Models Ems-235, Ems-165 | Apollo Endosurgery, Inc. | 2009 | — |
| +2 | K141058 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | 2014 | — |
| +3 | K150939 | Ensizor Endoscopic Scissors | Slater Endoscopy, LLC | 2015 | — |
| +4 | K242923 | SimpleSnip Endoscopic Suture Cutter (SC500160); SimpleSnip Endoscopic Suture… | Envision Endoscopy | 2024 | — |
| +2 | K180134 | Ensizor Monopolar Endoscopic Scissors | Slater Endoscopy, LLC | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OCZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OCZ device
- #1 K252800 KARL STORZ Endoscopic Accessories for Urologyscore 11.4 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Surgical Scissors marketed by Olympus Corp of America Named without a submission number | |
| * | — | Cuschieri Scissors marketed by Karl Storz Endoskope Named without a submission number |
What descends from it? (6)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K090583 (Apollo Endosurgery, Inc., 2009) has gone furthest, with 4 descendants of its own.
How does its category compare?
All OCZ devicesOCZ Endoscopic Grasping/Cutting Instrument, Non-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OCZ
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OCZ
Too few OCZ 510(k)s in any year since 2007 to give a median.
Recalls per year · OCZ
17in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OCZ
34in 2025
MAUDE reports naming product code OCZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 242 |
| 2016 | 1 | — | 0 | 759 |
| 2017 | 0 | — | 0 | 734 |
| 2018 | 0 | — | 0 | 252 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 1 | — | 0 | 21 |
| 2021 | 0 | — | 0 | 20 |
| 2022 | 0 | — | 17 | 33 |
| 2023 | 0 | — | 0 | 25 |
| 2024 | 1 | — | 0 | 37 |
| 2025 | 0 | — | 0 | 34 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The TeleMed Systems, Inc. Flexible Endoscopic Scissors are indicated for use for cutting of tissue when used through the working channel of a flexible or rigid endoscope.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K010412 · printed Nov 5, 2026
Cite this page
510(k) Report. “K010412: Flexible Endoscopic Scissors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K010412
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026